K092919 is an FDA 510(k) clearance for the MICROSCAN SYNERGIES PLUS MIC/COMBO PANELS, MODEL B1025. This device is classified as a System, Test, Automated, Antimicrobial Susceptibility, Short Incubation (Class II - Special Controls, product code LON).
Submitted by Siemens Healthcare Diagnostics (West Sacramento, US). The FDA issued a Cleared decision on October 23, 2009, 30 days after receiving the submission on September 23, 2009.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.1645.
| 510(k) Number | K092919 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 23, 2009 |
| Decision Date | October 23, 2009 |
| Days to Decision | 30 days |
| Submission Type | Special |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | LON — System, Test, Automated, Antimicrobial Susceptibility, Short Incubation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.1645 |